Time to completion of conditions required by Health Canada after approving new drugs: A cohort study

Some NOC/c take considerable time to be fulfilled. Health Canada should require studies to be underway at the time that a NOC/c is granted except in exceptional circumstances and it should be transparent about the completion date for confirmatory studies and provided detailed reports about any delays. In the case of delays that cannot be justified it should be given the power to impose significant financial penalties on manufacturers through the NOC/c pathway being converted from a policy into legislation.

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Publication Details

Journal
Health Policy
Published
2025-04-04
DOI
https://doi.org/10.1016/j.healthpol.2025.105314
Citations
1
Primary Topic
Health Systems, Economic Evaluations, Quality of Life
Type
article
Field-Weighted Citation Impact
3.13
Controls
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article

Time to completion of conditions required by Health Canada after approving new drugs: A cohort study

Joel Lexchin
1 citations
Health Policy
Health Systems, Economic Evaluations, Quality of Life
3.13
article

Time to completion of conditions required by Health Canada after approving new drugs: A cohort study

Joel Lexchin
article en
1 citations

Abstract

Some NOC/c take considerable time to be fulfilled. Health Canada should require studies to be underway at the time that a NOC/c is granted except in exceptional circumstances and it should be transparent about the completion date for confirmatory studies and provided detailed reports about any delays. In the case of delays that cannot be justified it should be given the power to impose significant financial penalties on manufacturers through the NOC/c pathway being converted from a policy into legislation.

Health PolicyVol. 155
University of Toronto (CA), York University (CA)
Openalex Percentile: Top 9%
Health Systems, Economic Evaluations, Quality of Life
3.13
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